Skip to main content
OpenTrials
Completed

NCT Number: NCT01077843

Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).

The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A recorded Ankylosing Spondylitis diagnosis in the database
  • A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
  • At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
  • Complete information on gender and birth year

Treatment and study plan

Etoricoxib

Drug

Cox-2 inhibitor

Other names: ARCOXIA®

Other Cox-2 inhibitors

Drug

Cox-2 inhibitor

Other Non-selective NSAIDs

Drug

Non-selective NSAID

No anti-inflammatory treatment

Other

No anti-inflammatory prescription

Primary outcomes

  1. Incidence rate of gastrointestinal ulcer, perforation or bleeding

    Time frame: First incident event for a given patient through 31-December-2017

  2. Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris

    Time frame: First incident event for a given patient through 31-December-2017

  3. Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack

    Time frame: First incident event for a given patient through 31-December-2017

  4. Incidence rate of fatal or non-fatal hemorrhagic stroke

    Time frame: First incident event for a given patient through 31-December-2017

  5. Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis

    Time frame: First incident event for a given patient through 31-December-2017

  6. Incidence rate of acute renal impairment or failure

    Time frame: First incident event for a given patient through 31-December-2017

  7. Incidence rate of hypertension

    Time frame: First incident event for a given patient through 31-December-2017

  8. Incidence rate of congestive heart failure or left ventricular dysfunction

    Time frame: First incident event for a given patient through 31-December-2017

  9. Incidence rate of sudden or unexplained death

    Time frame: First incident event for a given patient through 31-December-2017

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 1, 2010
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.